Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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No Description
Biotronik AG
3.5/15/140
In Commercial Distribution

  • 07640130447172 ()

  • Diameter: 3.5 mm
  • Length: 15 mm
  • Usable Length: 140 cm
434889

  • Bare-metal coronary artery stent
No Description
Biotronik AG
3.0/15/140
In Commercial Distribution

  • 07640130447165 ()

  • Usable Length: 140 cm
  • Length: 15 mm
  • Diameter: 3 mm
434888

  • Bare-metal coronary artery stent
No Description
Biotronik AG
2.5/15/140
In Commercial Distribution

  • 07640130447158 ()

  • Length: 15 mm
  • Diameter: 2.5 mm
  • Usable Length: 140 cm
434887

  • Bare-metal coronary artery stent
Elana Surical Kit HUD The Elana Sutrgical Kit HUD contains: The Elana Laser Catheter 2.0, The Elana Rings 2.6&2.8 and a vacuum extension tube. The Elana Surgical Kit HUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity.
Elana B.V.
1
In Commercial Distribution

  • M602801H00013 ()
801-H.00.01

  • Vascular-grafting anastomosis system
The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has been shown to increase the sensitivity of tumor cells to radiation or chemotherapy by the external application of electromagnetic energy. The system provides hyperthermia to solid tumors by generating and applying radio frequency (RF) energy.
Pyrexar Medical Inc.
BSD-2000U
Not in Commercial Distribution



  • Microwave hyperthermia system
The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has been shown to increase the sensitivity of tumor cells to radiation or chemotherapy by the external application of electromagnetic energy. The system provides hyperthermia to solid tumors by generating and applying radio frequency (RF) energy.
Pyrexar Medical Inc.
BSD-2000B
Not in Commercial Distribution



  • Microwave hyperthermia system
Proximal Inter-Phalangeal Joint Replacement Device
Ascension Orthopedics, Inc.
PIP-200-40D-WW
In Commercial Distribution

  • M269PIP20040DWW1 ()
  • 10381780000532 ()

  • Size: 40D
PIP-200-40D-WW

  • Proximal interphalangeal joint prosthesis, modular
Proximal Inter-Phalangeal Joint Replacement Device
Ascension Orthopedics, Inc.
PIP-200-30D-WW
In Commercial Distribution

  • M269PIP20030DWW1 ()
  • 10381780000525 ()

  • Size: 30D
PIP-200-30D-WW

  • Proximal interphalangeal joint prosthesis, modular
Proximal Inter-Phalangeal Joint Replacement Device
Ascension Orthopedics, Inc.
PIP-200-20D-WW
In Commercial Distribution

  • M269PIP20020DWW1 ()
  • 10381780000518 ()

  • Size: 20D
PIP-200-20D-WW

  • Proximal interphalangeal joint prosthesis, modular
Proximal Inter-Phalangeal Joint Replacement Device
Ascension Orthopedics, Inc.
PIP-200-10D-WW
In Commercial Distribution

  • M269PIP20010DWW1 ()
  • 10381780000501 ()

  • Size: 10D
PIP-200-10D-WW

  • Proximal interphalangeal joint prosthesis, modular
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